U.S., March 15 -- ClinicalTrials.gov registry received information related to the study (NCT03076437) titled 'Anti-CD19 Chimeric Antigen Receptor (CAR)-Transduced T Cell Therapy for Patients With B Cell Malignancies' on March 7.
Brief Summary: Autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) will be infused back to patients with B cell malignancies, including lymphoma and leukemia. The patients will be monitored after infusion of anti-CD19 CAR-transduced T cells for adverse events, persistence of anti-CD19 CAR-transduced T cells and treatment efficacy.
Objectives:
To evaluate the safety and the efficacy of anti-CD19 CAR-transduced T cell therapy for patients with B cell malignancies.
Eligibility:
Patients between 1 and 80 years of age, who have relapsed or refractory CD19-expressing B-cell malignancies (leukemia or lymphoma) that have not responded to standard treatments.
Patients with a history of allogeneic stem cell transplant who meet all eligibility criteria are eligible to participate.
Patients must have adequate organ functions.
Design:
Peripheral blood from patients will be collected for isolation of peripheral blood mononuclear cells (PBMCs), which will be transduced with a lentiviral or retroviral vector encoding anti-CD19 CAR containing a CD28 or 4-1BB and a CD3 zeta as costimulatory domains.
Patients will receive a lymphodepleting preconditioning regimen to prepare their immune system to accept modified T cells.
Patients will receive an infusion of their own modified T cells. They will remain in the hospital to be monitored for adverse events until they have recovered from the treatment.
Patients will have frequent follow-up visits to monitor the persistence of modified T cells and efficacy of the treatment.
Study Start Date:
Study Type: Interventional
Condition: Acute Lymphocytic Leukemia
Chronic Lymphocytic Leukemia
Lymphoma
Intervention: Combination Product: Drugs and Anti-CD19-CAR transduced T cells
Drug: Fludarabine On days -4 through -2, Fludarabine 30mg/m2 IV will be infused over 30 minutes. Drug: Cyclophosphamide On days -4 through -2, Cyclophosphamide 300mg/m2 IV will be infused over 60 minutes followed by fludarabine.
Biological: Anti-CD19-CAR transduced T cells Modified cells will be infused IV over 30 minutes (1-3 days after the last dose of fludarabine).
Recruitment Status: Recruiting
Sponsor: Shenzhen Institute for Innovation and Translational Medicine
Information provided by (Responsible Party): Shenzhen Institute for Innovation and Translational Medicine